Wrinkles Clinical Trial
Official title:
Treatment of Lateral Canthal Rhytides With Medium Depth Chemical Peel With or Without Pretreatment With Botulinum Toxin A: A Split-face, Rater-blinded Randomized Control Trial
This study is being done to find out if the use of botulinum toxin prior to a medium strength combination chemical peel (Jessner's peel followed by 35% Trichloroacetic acid peel) will improve the appearance of crow's feet wrinkles when compared to a chemical peel alone. Botulinum toxin type A is a purified substance, derived from a bacteria that block muscular nerve signals. Jessner's Peel, a combination of resorcinol (14g), salicylic acid (14g), and lactic acid (85%) in ethanol (95%), is a superficial chemical peel. These two products/procedures have been FDA approved to improve the appearance of facial wrinkles.
Status | Recruiting |
Enrollment | 12 |
Est. completion date | September 2013 |
Est. primary completion date | September 2013 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 30 Years to 75 Years |
Eligibility |
Inclusion Criteria: - Age 30 to 75 years old - In good health - Has static and dynamic lateral canthal wrinkles ("crow's feet") - Has the willingness and the ability to understand and provide informed consent and communicate with the investigator Exclusion Criteria: - Pregnant or lactating - Has received the following treatments: - botulinum toxin injections in the past 6 months - ablative laser procedure in the past 6 months - radiofrequency device treatment in the past 6 months - ultrasound device treatment in the past 6 months - medium to deep chemical peel in the past 6 months - temporary soft tissue augmentation material in the past year - semi-permanent soft tissue augmentation material in the past 2 years - permanent soft tissue augmentation material - Is planning to receive within the next 3 months, any cosmetic procedure (such as any chemical peels, botulinum toxin injections, ablative or non-ablative laser procedures, filler injections, radiofrequency procedures, dermabrasion, ultrasound and face lifting procedures) - Has an active infection on their face (excluding mild acne - Has a history of neuromuscular disorders - Has an allergy to albumin - Has an allergy to Aquaphor AND petroleum jelly - Has a history of bleeding disorders - Is unable to understand the protocol or to give informed consent - Has a mental illness |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | Loyola Dermatology | La Grange Park | Illinois |
Lead Sponsor | Collaborator |
---|---|
Loyola University |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in outcome of chemical peel if Botox A is added as pre-treatment | The primary objective of this study is to determine if pre-treating the orbicularis oculi muscles with botulinum toxin A improves the results of medium depth chemical peels when treating lateral canthal rhytides. | Baseline and 12 weeks | No |
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